https://orcid.org/0000-0003-0746-0280
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ABSTRACT
Introduction
Osteonecrosis of the femoral head (ONFH) is a refractory disease requiring joint replacement in young patients. Regenerative therapies have been developed.
Areas covered
This study surveyed clinical trials on regenerative medicine for ONFH. We extracted clinical trials on non-traumatic ONFH from the websites of five publicly available major registries (EuropeanUnion Clinical Trials Register ([EU-CTR],ClinicalTrials.gov, Chinese ClinicalTrial Registry [ChiCTR], University Hospital Medical InformationNetwork – Clinical Trial Registry [UMIN-CTR] and Australian New Zealand Clinical Trials Registry [ANZCTR]).The trials were classified into six categories based on purpose: surgical treatment, non-drug conservative treatment, conservative drug treatment, therapeutic strategy, diagnosis and pathogenesis, and regenerative therapy.) We extracted 169 clinical trials on ONFH. Of these, 37 were on regenerative medicine, including 29 on cell therapy. Surgical treatment was the most common treatment, followed by regenerative therapy.There were 9 clinical trials registered in the EU-CTR, with 5 on regenerative medicine; 79 trials registered on ClinicalTrials.gov, with 24 on regenerativemedicine; 54 trials registered in the ChiCTR, with 6 on regenerative medicine.
Expert opinion
The focus of the joint-preserving surgery has shifted to regenerative therapy based on using cell therapy in early-stage ONFH. The global standardisation of regenerative therapy is still ongoing.
Article highlights
ONFH is a refractory joint disease that causes femoral head collapse, pain, limitation of hip motion and gait disability.
ONFH is the main reason for THA in young generation. Younger patients are hesitant to undergo artificial joint surgery due to its restrictions on sports activity, the lifelong risks of infection and dislocation, high medical costs and potential for further revision surgery.
As with the SARS outbreak, attention needs to be paid to a possible rapid increase in corticosteroid-associated ONFH after the COVID-19 pandemic.
Regenerative medicine modified CD is considered the next treatment of interest to preserve hip joints. However, there has been limited validation for these newer regenerative therapies.
This study surveyed clinical trials on regenerative medicine for ONFH. There were 37 clinical trials on regenerative medicine, including 29 on cell therapy.
List of abbreviations
| ANZCTR | = | Australian New Zealand Clinical Trials Registry |
| BMC | = | Bone marrow cells |
| BG | = | Bone grafting |
| BMMNC | = | Bone marrow mononuclear cells |
| CD | = | Core decompression |
| ChiCTR | = | Chinese Clinical Trial Registry |
| FDAAA | = | Food and Drug Administration Amendments Act |
| FGF | = | Fibroblast growth factor |
| ICMJE | = | International Committee of Medical Journal Editors |
| ICTRP | = | International Clinical Trial Registry Platform |
| MSC | = | Mesenchymal stem cells |
| ONFH | = | Osteonecrosis of the femoral head |
| PTH | = | Parathyroid hormone |
| PRP | = | Platelet-rich plasma |
| RCT | = | Randomised controlled trials |
| SARS | = | Severe acute respiratory syndrome |
| THA | = | Total hip arthroplasty |
| UMIN | = | University Hospital Medical Information Network |
| WHO | = | World Health Organisation |
Declaration of interests
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contributions
Y Kuroda, T Kawai, Y Okuzu, Y Morita and S Matsuda drafted and completed the manuscript. All of the authors read and approved the final manuscript.
Ethics approval and consent to participate
This study is a survey of data from five public online clinical trial registries. Therefore, no protocol or relevant ethics committee approval was required.